FDA.reportPublic FDA data

MasimoSET® IntelliVue Module signal extraction pulse oximeter

Primary DI
00843997011495
Brand
MasimoSET® IntelliVue Module signal extraction pulse oximeter
Company
MASIMO CORPORATION
Model
3924
Published
2016-08-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQAOximeter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K040259000
K232389000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K040259000MASIMO SET INTELLIVUE PULSE OXIMETER MODULEMasimo Corp.2004-04-22DQA
K232389000Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVueMasimo Corporation2023-09-07DQA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00843997011495PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00843997011495008439970114958439970114950843997011495

GMDN Terms#

Term, Definition table
TermDefinition
Patient monitoring system module, pulse oximetryA small unit dedicated to the transcutaneous measurement of haemoglobin oxygen saturation (SpO2) in blood using light detection methods (spectrophotometry) after light is emitted from a light-emitting diode (LED) situated in the connected probe. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device or a connected module rack. The parent device operates as a mainframe computer displaying the pulse oximetry parameters provided by this module.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(949)297-7498TechService-US@masimo.com

Regulatory Flags#

DUNS number
780421038
Device count
1
Serial number
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10843997011003Radius VSM48422026-02-23
10843997016015Radius VSM46952026-02-23
00843997019163Radius VSM90372026-02-23
00843997019019Patient SafetyNet Lite950972026-02-23
00843997011006Radius VSM48422026-02-23
00843997016018Radius VSM46952026-02-23
00843997015530Rad-G YI Multisite Reusable Sensor46532021-10-08
10843997003381LNCS26902024-08-16
10843997003398LNCS26912024-08-16
10843997003404LNCS26922024-08-16
10843997003411LNCS26942024-08-16
10843997004968MasimoSET LNCS® E1™ SpO2 Adult Pulse Oximeter Adhesive Sensor291829182016-08-24
10843997010921RD rainbow SET-240282020-09-03
10843997010938RD rainbow SET-240292020-09-03
10843997013496O343842020-09-03
00843997010825rainbow SET418341832023-02-13
00843997010818rainbow SET41822022-11-21
10843997002797MasimoSET® LNCS® Adtx-3 SpO2 Adult Pulse Oximeter Adhesive Sensor260126012016-08-24
10843997002803MasimoSET® LNCS® Pdtx-3 SpO2 Pediatric Pulse Oximeter Adhesive Sensor260226022016-08-24
10843997002810MasimoSET® LNCS® Inf-3 SpO2 Infant Pulse Oximeter Adhesive Sensor260326032016-08-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048675785910Masimo SpO2 Module for Vista 300/SShanghai Draeger Medical Instrument Co.,Ltd.DQA2026-07-13
00010939962218N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
00093351041099N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
00845717013550N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
00845717013567N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
06972040113849N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
06972040113856N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
06931973400563CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973400730CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
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